SIMPLICITY DESENSITIZING- lidocaine gel

Simplicity Desensitizing by

Drug Labeling and Warnings

Simplicity Desensitizing by is a Otc medication manufactured, distributed, or labeled by Simplicity Laser, LLC, Results RNA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Lidocaine 4% w/w

Purpose

Topical anesthetic

Use:

temporarily relieves pain and itching due to:

• minor cuts
• minor scrapes
• sunburn
• minor skin irritations
• minor burns
• insect bites

Warnings:

For external use only.

• do not use in or near the eyes
• do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

• Allergic reaction occurs
• Condition worsens or does not improve within 7 days
• Symptoms clear up and return within a few days
• Redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
• Children under 2 years of age: Consult a doctor.

Other Information

Store at USP controlled room temperature 20-25 deg.C (68-77 deg.F).

Inactive ingredients

Ag,carbomer 940, deionized water

Simplicity Desensitizing Gel, 1 fl oz/30mL (

69109-004-30)

INGREDIENTS AND APPEARANCE

SIMPLICITY DESENSITIZING 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69109-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69109-004-30	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/15/2014

Labeler -  Simplicity Laser, LLC (079456595)

Establishment
Name	Address	ID/FEI	Business Operations
Results RNA, LLC		078395000	manufacture(69109-004)